|Radient Pharma soars on news of cancer test. International Stem Cell surges on skin care product|
|By BioMedReports.com Staff|
|Thursday, 08 April 2010 19:03|
Below is a list of the companies that made news in the healthcare sector on Thursday, April 08, 2010.
Radient Pharmaceuticals Corporation (AMEX:RPC) soared today, after the company, through its US-based subsidiary AMDL Diagnostics Inc., announced it has signed an exclusive 5-year sales, marketing, and distribution agreement with Jaiva Technologies, Inc., a US multinational biotechnology company, and its affiliate, Gaur Diagno (New Delhi), collectively referred to as ("JTGD"). Under the terms of the agreement, JTGD has the exclusive rights to distribute RPC's Onko-Sure™ in vitro diagnostic cancer test in the country of India and is responsible for product sales, marketing, and governmental regulatory in the territory.
Of primary importance, JTGD anticipates receiving Indian government support in various regions to implement the Onko-Sure cancer test as a cancer screening tool for populations at risk. This will be the first large scale Onko-Sure cancer testing/screening initiative. India is a key emerging healthcare market with immense potential to improve quality of life and mortality for its citizens.
Radient Pharmaceuticals was also profiled today, here on BioMedReports, with an in-depth look at the company and an interview with the CEO.
After rising more than 11% on Wednesday, the stock exploded today, jumping 85% or 32 cents to close the regular session at 70 cents. Shares continued to climb another 10% in the after hours market.
International Stem Cell Corporation (OTCBB: ISCO), moved higher after the company announced today that its wholly owned subsidiary, Lifeline Skin Care Inc., has achieved positive results in human safety tests of its cosmetic products and is moving forward with arrangements with Cosmetic Enterprises Ltd. for the manufacture of three cosmetic products. These developments allow Lifeline Skin Care to plan a launch of its cosmetic product line in the late summer or fall of 2010.
Cosmetic face products developed by Lifeline Skin Care Inc. contain extracts from human parthenogenetic stem cells (hpSC) combined with a vitamin complex and other active ingredients. The products utilize a form of nanotechnology to deliver concentrated active ingredients to damaged skin. Laboratory tests show that an active "complex" of stem cell extract has the ability to rejuvenate skin. Also, early human trials show that these cosmetic products moisturize skin and strongly indicate the ability to decrease the depth of wrinkles and provide factors that lead to anti-aging effects.
The results of recent human safety tests show there were no identifiable signs or symptoms of sensitization (contact allergy). Safety testing is a series of tests to insure the product does not cause negative reactions such as irritation to the skin. This completed round of testing allows Lifeline Skin Care to move forward confidently with its commercial manufacturing plans.
Shares moved up more than 13% on the news, closing the day at $2.34.
In other news Thursday:
Abraxis BioScience, Inc. (NASDAQ: ABII), a fully integrated biotechnology company, announced that the updated survival findings from a Phase I/II clinical trial evaluating the chemotherapy agent ABRAXANE® for Injectable Suspension (paclitaxel protein-bound particles for injectable suspension) (albumin-bound) in combination with gemcitabine for first-line treatment of patients with metastatic pancreatic cancer will be discussed during a keynote address on April 20 at the 101st Annual Meeting of the American Association for Cancer Research (AACR) being held in Washington, D.C. The updated survival data points follow our interim data from the Phase I/II pancreatic clinical trial presented at the 45th Annual Meeting of the American Society of Clinical Oncology. This trial data will be locked shortly, and the resulting protocols have been employed for an ongoing Phase III trial currently enrolling patients..
BioClinica™, Inc., (NASDAQ: BIOC), a global provider of clinical trial management services, today announced the release of BioClinica WebSend, a system that simplifies and accelerates image collection for clinical studies. WebSend transfers and tracks medical images in real-time, offering key benefits over the standard manual transport methods commonly used in imaging trials, including faster delivery of image data, enhanced data quality with fewer site queries, and reduced cost.
Bond Laboratories, Inc. (OTCBB:BNLB), an innovative manufacturer of functional beverages and nutritional products, announced that for the quarter ending March 31, 2010 sales for its NDS Division grew 21% over the same period in 2009.
According to Ohio-based research firm Freedonia Group, the U.S. Nutraceutical Industry between 2008 and 2013 is projected to grow just slightly over 4% per year. Based on this projection, NDS’ growth outperformed the overall industry by approximately 500%. NDS further reported that during March sales grew an amazing 31% over the same month last year.
"Our Amplify™ and Pump Fuel™ supplements were the primary growth vehicles behind these exceptional results," stated Bond CEO, John Wilson. "Their growth exceeded even our most optimistic projections, and we are encouraged to see performance accelerate through the quarter. We are extremely excited about the future prospects of NDS."
Celgene Cellular Therapeutics (CCT), a wholly owned subsidiary of Celgene Corporation (NASDAQ: CELG ), today announced initial results from a Phase I multicenter safety study of PDA-001 in treatment-resistant Crohn's Disease. PDA-001 is an immunomodulatory therapy consisting of human placenta-derived cells obtained from CCT’s proprietary processes.
In the study, twelve patients with active moderate-to-severe Crohn’s Disease who were unresponsive to at least one prior therapy were given two infusions of PDA-001 one week apart. The first six patients received two infusions of 2x108 cells (Low Dose) and the next six received two infusions of 8x108 cells (High Dose).
The study met its primary endpoint of safety and demonstrated encouraging clinical benefit including clinical remission. Based on these results, the company has decided to further evaluate the clinical potential of PDA-001 in multiple Phase II studies across a number of disease states.
Cubist Pharmaceuticals, Inc. (NASDAQ: CBST), a leading acute care therapeutics company, today announced the enrollment and dosing of the first subject in its Phase 2 trial with CB-183,315, an antibacterial drug candidate intended to treat patients with a severe and sometimes life-threatening diarrhea caused by Clostridium difficile known as C. difficile-associated diarrhea, or CDAD. The trial is expected to enroll more than 200 subjects at 28 sites in the United States and Canada.
Dendreon Corporation (Nasdaq:DNDN) today announced that Varun Nanda has joined the company as senior vice president of global commercial operations, effective April 19, 2010. Mr. Nanda most recently served as the senior vice president and global head of oncology at Roche/Genentech, where he led the global product strategy for all oncology molecules, from pre-clinical research through commercialization. "With more than twenty years of commercial experience, Varun will help guide our team as we move closer to realizing our mission of transforming the lives of cancer patients," said Hans Bishop, executive vice president and chief operating officer. "Varun's depth of experience launching Avastin® and leading several breakthrough global oncology products will be highly relevant to our transformation from a purely R&D organization into a world-class commercial organization."
While most recently at Genentech, Mr. Nanda oversaw global marketing and lifecycle development for products in Roche/Genentech's oncology franchise. Prior to assuming that role, Mr. Nanda served as vice president of Avastin sales and marketing, leading an organization of nearly 400 people and achieving U.S. sales of more than $3 billion within five years of launch. Mr. Nanda also held the roles of vice president and senior director for oncology sales and marketing at Genentech. Prior to joining Genentech, Mr. Nanda was director of brand management and product manager of endocrinology at Novo Nordisk Pharmaceuticals, Inc.
Generex Biotechnology Corporation (Nasdaq:GNBT) the leader in drug delivery for metabolic diseases through the inner lining of the mouth, today announced that it has entered into a common stock purchase agreement with Seaside 88, LP, a private investment limited partnership. Seaside has committed to purchase up to 49,455,130 shares of Generex common stock. Seaside will purchase up to 2,000,000 shares every two weeks in up to 25 tranches (with up to 1,455,130 shares purchased in the final tranche). Today, Generex and Seaside closed the first tranche of 2,000,000 shares for gross proceeds to Generex of $945,180 at a per share price of $0.47259, being 89% of the 10-day volume weighted average trading price (VWAP) of the Company's common stock on the NASDAQ Capital Market immediately prior to the closing.
Inovio Biomedical Corporation (NYSE Amex: INO), a leader in DNA vaccine design, development and delivery, announced today that the company has completed enrollment of all subjects for its therapeutic cervical cancer vaccine (VGX-3100) phase I trial. VGX-3100 is a DNA vaccine targeting the E6 and E7 proteins of human papillomavirus (HPV) types 16 and 18, and is delivered via in vivo electroporation.
Labopharm Inc. (TSX: DDS; NASDAQ: DDSS) today announced its wholly owned subsidiary, Labopharm Europe Limited, has completed a licensing and distribution agreement for once-daily tramadol with Nippon Shinyaku Co., Ltd. of Japan.
Labopharm will receive an up-front payment upon signature of the agreement and is eligible to receive additional payments related to the achievement of certain regulatory and commercialization milestones.
Æterna Zentaris Inc. (NASDAQ: AEZS, TSX: AEZ), a late-stage drug development company specialized in oncology and endocrine therapy, today announced the initiation of a Phase 3 registration clinical trial with perifosine (KRX-0401) ), the Company's novel, potentially first-in-class, oral anti-cancer agent that inhibits Akt activation in the phosphoinositide 3-kinase (PI3K) pathway, for the treatment of refractory advanced colorectal cancer. The trial is sponsored and conducted by Keryx Biopharmaceuticals (Nasdaq:KERX), Æterna Zentaris' partner and licensee for perifosine in the United States, Canada and Mexico. Æterna Zentaris has also out-licensed perifosine to Handok in South Korea, while retaining rights for the rest of the world. Both Aeterna Zentaris and Keryx moved higher on the news.
Impax Laboratories, Inc. (NASDAQ: IPXL) today announced that Allen Chao, Ph.D., has been elected to the Company’s board of directors. Dr. Chao is currently Chairman of Newport Healthcare Advisors, LLC, a healthcare investment management and consulting company. Dr. Chao was a co-founder of Watson Pharmaceuticals, Inc., serving as a director from 1985 to May 2008, Chairman of the board of directors from May 1996 to May 2008, and Chief Executive Officer from 1985 to September 2007.
Infinity Pharmaceuticals, Inc. (Nasdaq:INFI), moved higher today as the innovative drug discovery and development company announced that members of its scientific teams will be reporting preclinical data from its novel Hedgehog pathway inhibitor program -- an emerging area of cancer research -- during the 2010 American Association of Cancer Research (AACR) Annual Meeting being held in Washington, D.C. from April 17 through April 21, 2010. Infinity's novel Hedgehog pathway inhibitor, IPI-926, is a potent, orally delivered small molecule drug candidate that has demonstrated significant anti-tumor activity in multiple preclinical cancer models. IPI-926 is currently being evaluated in a Phase 1 clinical trial in patients with advanced solid tumors.
NewCardio, Inc. (OTC Bulletin Board:NWCI.ob), has signed a Master Services Agreement with Clinilabs, a New York-based contract research organization that provides early phase and specialty clinical drug development services to the pharmaceutical industry. Clinilabs has licensed NewCardio's QTinno™ software solution in order to perform fully-automated cardiac safety analyses in cardiac intensive and thorough QT studies. In addition, Clinilabs has signed a services work order, including standard operating procedures (SOP) and validation kits, as well as professional services, so NewCardio can assist Clinilabs in developing an ECG core laboratory.
Oncolytics Biotech Inc. (TSX:ONC, NASDAQ:ONCY) announced today that a paper entitled "Antiangiogenic cancer therapy combined with oncolytic virotherapy leads to regression of established tumors in mice," co-senior authored by Dr. Richard Vile of the Department of Immunology, Mayo Clinic, Rochester, Minnesota, USA, and Dr. Kevin Harrington of the Institute of Cancer Research, London, UK, was published in the online version of the Journal of Clinical Investigation on April 1, 2010. The research demonstrated that combining VEGF(165) inhibitors such as Avastin or Sunitinib with systemic delivery of REOLYSIN(R) leads to substantial regression and cure of established tumors in immunocompetent mice. This approach led to direct tumor cell lysis (break down) and triggered innate immune-mediated attack on the tumor vasculature.
Patient Portal Technologies, Inc. (OTCBB:PPRG) announced today financial results for the first quarter of fiscal 2010 ending March 31, 2010. The Company reported strong first quarter 2010 results with significant increases in all profit measurements as well as a strong backlog of service revenue opportunities. Patient Portal Technologies, Inc. is a Total Satisfaction company, assisting hospitals to improve the patient's experience before, during and after their hospital stay. The company provides its products and solutions to hospitals and healthcare facilities throughout the entire United States. Business demand for the Total Satisfaction Platform continues to be strong and management expects the trend to continue throughout the remainder of the year. The Company continues to focus its resources on strengthening its relationship and creating new partners to assist with the growth plan. Company CEO, Kevin Kelly commented, "Hospitals are keenly focused on improving patient satisfaction and interested in the Company's approach and ability to deliver high-impact solutions that meet their needs.
Perrigo Company of South Carolina, Inc. (Nasdaq: PRGO; TASE) announced today that it won two favorable jury verdicts against Rexall Sundown, Inc. in an unfair competition lawsuit that was brought in the U.S. Eastern District Court of New York. The jury unanimously found that Perrigo's statement, used on wholesalers' and retailers' store brand packaging for joint care products containing Glucosamine and Chondroitin, inviting consumers to compare the products to Rexall Sundown's Osteo Bi-Flex, is not false and misleading and does not violate Section 43 of the Lanham Act.
In addition, the jury ruled in Perrigo's favor on its false advertising counterclaim against Rexall Sundown under Section 43 of the Lanham Act based on a statement used by Rexall Sundown on packaging from 2006 to 2008. The jury determined that the Rexall Sundown statement was false and misleading and awarded Perrigo damages.
Pharmasset, Inc. (Nasdaq:VRUS) announced today that dosing has initiated in a phase 1, single ascending dose (SAD) study in healthy volunteers with PSI-938, a third generation purine nucleotide analog polymerase inhibitor of hepatitis C virus (HCV). Pharmasset recently filed an Investigational New Drug Application (IND) with the Food and Drug Administration (FDA).
Seattle Genetics, Inc. (NASDAQ:SGEN), and Takeda Pharmaceutical Company Limited (TOKYO:4502) and its wholly owned subsidiary Millennium: The Takeda Oncology Company today announced the initiation of a phase III clinical trial of brentuximab vedotin (SGN-35) for post-transplant Hodgkin lymphoma patients. Brentuximab vedotin is an antibody-drug conjugate (ADC) targeted to CD30, which is expressed on malignant Hodgkin lymphoma cells. The phase III trial, also known as AETHERA, will evaluate brentuximab vedotin versus placebo for the treatment of patients at high risk of residual Hodgkin lymphoma following autologous stem cell transplant (ASCT).
Tongjitang Chinese Medicines Company (NYSE:TCM), a leading specialty pharmaceutical company focusing on the development, manufacturing, marketing and selling of modernized traditional Chinese medicine in China, today announced that it received a letter dated April 8, 2010, proposing to acquire all of the outstanding ordinary shares of the Company, including ordinary shares outstanding in the form of American Depositary Shares, in a transaction under Cayman Islands law that would result in the Company becoming a privately-held company.
The proposal is from Hanmax Investment Limited, a company controlled by Mr. Xiaochun Wang, chairman of the Company's board of directors and chief executive officer of the Company, and Fosun Industrial Co., Limited, a company incorporated in Hong Kong . The transaction is intended to be structured as a merger of the Company with a new joint venture incorporated in the Cayman Islands and owned solely by the Bidding Parties. The Bidding Parties propose to pay US$1.125 in cash, without interest, for each outstanding share of the Company (or US$4.50 per ADS), excluding ordinary shares and ordinary shares represented by ADSs that are owned by the Bidding Parties. The proposal is subject to, among other things, negotiation of a definitive merger agreement and the availability of financing. The Board members, except Mr. Xiaochun Wang, are reviewing the proposal.
ULURU Inc. (NYSE Amex: ULU) announced today that the Company will be presenting clinical data at the 2010 American Professional Wound Care Association(APWCA) National Conference in Philadelphia, PA April 8-11, 2010. At the conference, Altrazeal™ clinical evidence, best clinical practices, and advanced clinical applications will be showcased in both podium and poster presentations.
Dr. Gregory Bohn, MD, FACS, Medical Director of the Trinity Center for Wound Care and Hyperbaric Medicine in Bettendorf, Iowa, will be giving a podium presentation on Saturday, April 10, titled" Transforming Powder Wound Dressing Relieves Pain and Manages Moisture, Restoring Quality of Life". In addition, Dr. Bohn will present numerous additional posters on topics including, the use of Altrazeal™ in conjunction with mesh skin graft fixation, Altrazeal™ as a cost-effective management technique in difficult to heal wounds, use of Altrazeal with negative pressure wound therapy and the unique physical properties of Altrazeal™ and their potential impact on wound healing.
ZIOPHARM Oncology, Inc. (Nasdaq: ZIOP), announced today it has initiated a Phase I/II study at Memorial Sloan-Kettering Cancer Center for the novel, mathematically - determined administration of oral indibulin (Zybulin™ or ZIO-301) in the treatment of metastatic breast cancer. Indibulin is a novel, oral tubulin binding agent that targets both mitosis and cancer cell migration. It is expected to have several potential benefits, including oral dosing, application in multi-drug resistant tumors, no neuropathy, and minimal overall toxicity.